Complications associated with transobturator sling procedures

Sarah Hamilton Boyles, Renee Edwards, William Gregory, Amanda Clark

Research output: Contribution to journalArticle

69 Scopus citations

Abstract

This study aims to determine the complications associated with trans-obturator slings as reported to a national database. We required "MAUDE", a database that collects reports of complications associated with medical devices and which is maintained by the Food and Drug Administration. We searched for complications associated with three different, commercially available trans-obturator slings. We then tabulated the results by type of complication, by date of occurrence, and by type of sling. Between January 2004 and July 2005, 140 reports of 173 complications associated with trans-obturator tapes were reported to the MAUDE database. Previously unreported injuries, such as obturator nerve injuries, large blood losses (≥600cc), and ischiorectal fossa abscesses, were documented. Serious complications occur with the trans-obturator tape systems, but the rates are unknown due to database limitations. The type of complication appears to differ between devices and this may reflect different implantation systems and different polypropylene mesh formulations. Improved tracking of device complications is necessary to maximize patient safety.

Original languageEnglish (US)
Pages (from-to)19-22
Number of pages4
JournalInternational Urogynecology Journal
Volume18
Issue number1
DOIs
StatePublished - Jan 2007

Keywords

  • Complications
  • MAUDE database
  • Stress
  • Trans-obturator sling
  • Urinary incontinence

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Urology

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